Endometrial Neoplasms
Conditions
Interventions
investigational material(s)
Generic name etc : olaparib, durvalumab, durvalumab placebo, olaparib placebo, Carboplatin, Paclitaxel
INN of investigational material : -
Therapeutic category code : 429 O
Sponsors
AstraZeneca KK
The Gynecologic Oncology Group (GOG) Foundation Inc, The European Network for Gynaecological Oncological Trial groups (ENGOT)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18 years at the time of screening or more and female. - Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed. - Patient must have endometrial cancer in one of the following categories: 1. Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy), 2. Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy) 3. Recurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor. - Naive to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse - FPPE tumor sample must be available for MMR evaluation. - Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.
Exclusion criteria
Exclusion criteria: - History of leptomeningeal carcinomatosis. - Brain metastases or spinal cord compression. - Prior treatment with PARP inhibitors. - Any prior exposure to immune-mediated therapy, including (but not limited to) other anti CTLA-4, anti-PD-1, anti-PD-L1, or anti-programmed-cell-death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy bioavailability - | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy safety - | — |
Countries
Australia, Belgium, Brazil, Canada, China, Columbia, Estonia, Greece, Holland, Hong Kong, Israel, Italy, Japan, Lithuania, Poland, Russia, Singapore, South Korea, Spain, USA
Contacts
Public ContactKazushige Hibi
Astrazeneka K.K
Outcome results
None listed